Apparatus for attaching surgical suture components

ABSTRACT

The present invention relates to an apparatus for attaching surgical sutures to eyeless surgical needles. The apparatus includes a system for automatically presenting the surgical needles to a frame which positions and maintains the needle for subsequent swaging and a rotating die system which selectively impacts the needle to secure the suture thereto.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical sutures and their production.More particularly, the invention relates to an apparatus and method forattaching surgical needles to surgical sutures.

2. Description of the Related Art

The trend to develop and produce surgical sutures attached to eyelesssurgical needles is continuously evolving. The most common surgicalsuture of this type is a single-use needle of appropriate size and shapewhich is attached to the end of the suture, so that the needle is usedonce and then discarded.

The attachment can be accomplished by use of a "drilled end" needle,that is, one in which a concentric aperture is formed in the end face ofthe needle, in which the suture is placed in the aperture and the needleis crimped around the suture. Alternatively, a "flanged" needle may beutilized in which a U-shaped channel is stamped into the end of theneedle with the ends of the "U" being crimped about the suture to holdthe suture together. The attachment must be one which is predictablysecure, causes a minimum of damage to tissue, is convenient for theusing surgeon, permits sterilization and entails reasonable costs. Inaddition, the attachment must withstand the rigors of manufacture,sterilization, storage, shipment and use.

With conventional crimping operations a crimp is created between severaldies which close to a fixed gap. Any variation in the crimping dies, theneedle size, the hole size, or the suture size alters the degree ofcrimp.

Conventional crimping methods require the back end of the needle bestruck with two half moon shaped dies. The needle is then manuallyrotated 90° and the needle is struck again with the dies. The manualintervention in the production of surgical sutures with eyeless needlesreduces production efficiency and increases the associated costsincurred in their manufacture. Manual intervention also adds to theoperator's fatigue caused by continuous repetitive movement as well asthe non-ergonomic design of such crimping apparatus.

To date, techniques devised for connecting such suture components in amanner to perform within the preferred guidelines are not as effectivefor high speed production of surgical sutures as would otherwise bedesirable.

SUMMARY OF THE INVENTION

The present invention relates to an apparatus for feeding surgicalneedles to a needle crimping apparatus while minimizing occurrences ofneedle point damage. The needle crimping apparatus avoids theaforementioned disadvantages of conventional crimping operations byautomatically rotating a pair of dies approximately 90° so as to reducethe need for manual rotation of the needle as described above. Theneedle feeding apparatus includes a container adapted to receive curvedsurgical needles and orientating the surgical needles in a predefinedposition for subsequent processing, a transmission member for receivingthe orientated needles from the container at a receiving position andtransferring the needles to a presenting position, and means fortransferring the needles between the presenting position and a crimpingposition.

Preferably, the container is an uncoated vibratory bowl which has atleast one sweep positioned on a bottom portion of the bowl and at leastone ramp which orientates the needles while transferring the needlesfrom the bottom portion of the bowl to the receiving position andsubstantially avoiding needle point damage.

The transmission member of the present invention includes a vibratoryrail with a substantially cylindrical shape which is adapted to supportand transfer the needles to the presenting position. Preferably, therail has a radius equal to or less than the radius of curvature of thecurved surgical needle so as to prevent damage to the needle point.

The transferring means of the present invention includes means forgrasping needles in the presenting position and for transferring thegrasped needle to a needle pusher track, and means for moving the needlealong the pusher track to the crimping position. The grasping andtransferring means has a drive member adapted for movement between thepresenting position and the crimping position, and a pair of jawssecured to the drive member and movable between an open position and aclosed position.

In an alternative embodiment a system for attaching surgical sutures tosurgical needles is provided. Generally, the system utilizes the abovedescribed needle feeding apparatus to feed the surgical needles to asuture attaching apparatus. The system includes means for receiving andorienting surgical needles in a predefined arrangement, means forreceiving the oriented needles from the receiving and orienting meansand for transferring the needles to a presenting position, means fortransferring the needles between the presenting position and a crimpingposition, and means for crimping a surgical suture to the transferredneedles.

The system also includes means for guiding the surgical suture into abore in the end face of the needle. The suture guide means has a firstguide arm and a second guide arm arranged so that at least one of thefirst and second guide arms is movable either automatically or manuallyrelative to the other. The first and second guide arms are adapted toreceive a suture and direct the suture into the bore in the end face ofthe needle.

The crimping means of the above described system includes support means,die means attached to the support means for selectively impacting theneedle so that a portion of the needle is deformed to maintain thesuture therein, the die means being rotatable between at least twopositions. First drive means is provided for actuating the die means toimpact the needle, and second drive means is provided for rotating thedie means at least to a second position respective to the needle.

Generally, the die means includes a die cartridge having at least onejaw slidably secured thereto and gear means secured to the die cartridgeand operatively connected to the second drive means for translatingmovement of the second drive means to rotational movement of the diecartridge.

The first drive means includes a first pair of arms pivotally connectedto a first drive member and positioned adjacent the die cartridge onopposite sides thereof and a second pair of arms pivotally connected tothe first drive member and positioned adjacent the die cartridge onopposite sides thereof and out of phase with the first pair of arms.

The second drive means is adapted to rotate the die means between thefirst and second positions. In the preferred embodiment, the die meansis adapted to impact the needle in the first and second positions, wherethe second position is rotatably oriented at least a predeterminedangular position from the first position. Preferably, the secondposition is oriented at least about 90° from the first position. Thesecond drive means includes rack gear means secured to a second drivemember and adapted for engagement with the gear means such that linearmovement of the rack gear means causes rotational movement of the diecartridge.

The apparatus also includes needle gripping means for maintaining theneedle in a predetermined position when the die means is actuated. Inaddition, the apparatus of the present invention may further includeguide means positioned adjacent the die means for guiding the sutureinto a bore in the end face of the needle. The guide means is adjustablein at least two directions, preferably, horizontal and vertical.

Control means is provided and operatively connected to the first andsecond drive means for selectively activating the first and second drivemeans. Generally, the control means includes pneumatic and electricalcontrols and switch means for automatically terminating the impactingand the rotation of the die means.

The present invention also provides a vibrating container for receivingand orientating curved surgical needles. The container includes a base,at least one side wall, and a needle receiving member positioned on thebase. Sweeps are positioned on the base and are provided for orientingthe curved surgical needles to a predetermined orientation. A ramp issecured to the side wall of the container and is provided to process thecurved surgical needles from the base to a needle presenting position onthe side wall. Preferably, the container is a stainless-steel bowl.

The present invention also provides a method for attaching surgicalsuture components. The method includes the following steps automaticallyfeeding a surgical needle having a bore in an end face, from a needlecontainer to a position between a pair of dies, releasably maintainingthe needle between the pair of dies, inserting a surgical suture intothe needle bore, and impacting the needle with the pair of dies so as tosecure the suture to the needle.

In an alternative embodiment, after the needles are initially impacted,the dies may be rotated, preferably 90 degrees, and the needle is thenimpacted a second time to further secure the suture to the needle.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described hereinbelow withreference to the drawings wherein:

FIG. 1 is a perspective view of the suture needle attaching apparatus ofthe present invention;

FIG. 2 is a front elevational view of the suture needle attachingapparatus taken along lines 2--2 of FIG. 1;

FIG. 3 is a top plan view of the suture needle attaching apparatus takenalong line 3--3 of FIG. 1;

FIG. 4 is an enlarged top plan view of the crimping zone of theapparatus of FIG. 1;

FIG. 5 is a front elevational view of the suture needle attachingapparatus taken along lines 5--5 of FIG. 1, illustrating the diesrotated 90° and the needle positioned for crimping;

FIG. 6 is a side elevational view of the rotating and crimping systemassociated with the suture needle attaching apparatus of the presentinvention;

FIG. 7 is an enlarged perspective view with parts separated of a portionof the rotating and crimping systems of FIG. 6;

FIG. 8 is a plan view of a portion of the dies of the crimping system ofFIG. 6, illustrating a "lap-overlap" die configuration;

FIG. 9 is a plan view of a portion of an alternative embodiment of thecrimping system of FIG. 6, illustrating a "clover leaf" dieconfiguration;

FIG. 10 is a side elevational view of a portion of the die cartridgeshown in FIG. 7, illustrating the sliding relationship between the diecartridge and the dies;

FIG. 11 is a side elevational view of a portion of the rotating andcrimping systems of FIG. 6, illustrating the die cartridge in a normalposition and the dies in an open position;

FIG. 12 is a side elevational view, greatly enlarged, of the diecartridge of FIG. 11, illustrating the dies in a preset position;

FIG. 13 is a plan view of the dies of FIG. 8 in the normal position andhaving a crimped needle positioned therebetween;

FIG. 14 is a plan view of the dies of FIG. 13, illustrating the dies ina rotated position and the needle crimped therebetween;

FIG. 15 is a side elevational view, greatly enlarged, of the diecartridge of FIG. 11, illustrating the dies in a crimping position;

FIG. 16 is a side elevational view similar to FIG. 11, of the rotatingand crimping system, illustrating the die cartridge in a rotatedposition and the dies in an open position;

FIG. 17 is a side elevational view of the rotating and crimping systemsof FIG. 16, illustrating the dies in a crimping position;

FIG. 18 is a side elevational view of the die cartridge taken alonglines 18--18 of FIG. 5 illustrating the dies in a crimped position;

FIG. 19 is a perspective view of a portion of a surgical suture crimpedto a surgical needle;

FIG. 20 is a partial cross-sectional view of the crimped surgical suturetaken along lines 20--20 of FIG. 19;

FIG. 21 is a front plan view of the needle presenting system of thepresent invention, illustrating a needle bowl, a rail feeding system, apick and place system and a needle pusher system;

FIG. 22 is a top plan view of the needle bowl of FIG. 21, illustratingsweeps and a narrowed ramp portion for orienting needles for subsequentpresentation to the rail feeding system;

FIG. 23 is a top plan view of a portion of the needle bowl of FIG. 22,illustrating the orientation of a needle by a sweep positioned on thebase of the bowl;

FIG. 24 is a partial cross-sectional view of the needle bowl of FIG. 22,illustrating a needle properly positioned for presentation to the railfeeding system and a sweep in the lower portion of the bowl for properlyorienting the needle with its barrel portion facing the center of thebowl;

FIG. 25 is a partial cross-sectional view of the rail feeding system ofFIG. 22 taken along line 25--25 and illustrating the proper orientationof a needle on the rail feeding system;

FIG. 26 is a partial cross-sectional view of the needle bowl and therail feeding system of FIG. 22 taken along line 26--26 and illustratingthe motion of a needle during presentation to the rail feeding system;

FIG. 27 is a perspective view of the rail feeding system and the pickand place system of the present invention;

FIG. 28 is a front plan view, greatly enlarged, of a portion of the railfeeding system as a needle is being grabbed by the jaws of the pick andplace system;

FIG. 29 is a cross-sectional view of the rail feeding system of FIG. 28taken along line 29--29 and illustrating a needle guide arm whichprevents the needle from dislodging from the rail;

FIG. 30 is a cross-sectional view similar to FIG. 29, illustrating arail of the feeding system removably secured to a vibrating frame;

FIG. 31 is a front plan view of a portion of the pick and place systemof the present invention illustrating the motion of the jaws whenpicking and placing a needle;

FIG. 32 is a perspective view of the needle pusher system of the presentinvention and the die rotating and crimping system, illustrating amanually operated suture guide attached to the die rotating and crimpingsystem;

FIG. 33 is a top plan view of a portion of the needle pusher system ofFIG. 32;

FIG. 34 is a side elevational view in partial cross-section of theneedle pusher system of FIG. 33 taken along line 34--34 and illustratingthe pneumatic piston for moving a slide member and a motion limitingswitch;

FIG. 35 is a side elevational view of a manually operated needle sutureguide;

FIG. 35A is a top plan view of a portion of the manually operated needlesuture guide of FIG. 35;

FIG. 36 is a perspective view similar to FIG. 32, illustrating anautomatically operated needle holder and suture guide;

FIG. 37 is a side elevational view, greatly enlarged, of the jaws of theneedle suture guide FIG. 36, illustrating the jaws in an open position;

FIG. 38 is a side elevational view of the jaws of the needle sutureguide similar to FIG. 37, illustrating the jaws in a closed position;

FIG. 39 is a side elevational view of a portion of the automaticallyoperated needle suture guide of FIG. 36, illustrating two of the threedimensional adjusting screws; and

FIG. 40 is a front plan view of the automatically operated needle sutureguide of FIG. 36, illustrating two of the three dimensional adjustingscrews.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially to FIG. 1, the apparatus 10 generally includes frame12 to support the various components of the apparatus, control panel 14and die rotating and crimping system 16. Control panel 14 may be securedto, or independent of frame 12 and provides electrical and pneumaticcontrols for the active components of apparatus 10. The electrical andpneumatic controls and devices for control panel 14 are preferably of atype known in the art and include, for example, electrical and pneumaticswitches, air pressure gauges and light indicators. Die rotating andcrimping system 16 is secured to frame 12 as shown and is provided torotate and crimp the crimping dies.

Referring now to FIGS. 2-4, frame 12 further includes horizontal supporttable 18 which is provided to support the needle 24 and is adjustable inthree directions of a three-dimensional coordinate system, as shown byarrows A, B and C. For example, as viewed in FIG. 1, direction "A"represents vertical movement, direction "B" represents fore and aftmovement and direction "C" represents lateral (i.e., left and right)movement.

Referring once again to FIGS. 2-4, table 18 rests on vertical bracket 13and the bracket rests on support base 15. Support base 15 is pivotallymounted to frame 12 by pivot pin 17 to provide pivotal movement of table18, bracket 13 and support base 15. Thumb screw 19 secures support base15 to frame 12 so that table 18 is maintained in a fixed relation to theframe. Loosening of thumb screw 19 permits free pivotal movement oftable 18 with respect to frame 12. Such pivotal movement permits accessto the die rotating and crimping system 16 to facilitate ease of removalor insertion of die cartridge 20 into the die rotating and crimpingsystem 16. Needle grippers 22, best shown in FIG. 4, are secured totable 18, adjacent die cartridge 20 so that when needle 24 is positionedbetween needle grippers 22 the needle will automatically become alignedwith the working surface of the crimping dies as shown in crimping area200 of FIGS. 3 and 4. Preferably, needle grippers 22 are pneumatic jawscontrolled by control panel 14 as will be described in further detailbelow. Hand rest 23 is secured to frame 12 adjacent die cartridge 20 andprovides the operator with an ergonomic hand rest when inserting suturesinto the needle and when operating the apparatus of the presentinvention.

Referring again to FIG. 1, emergency stop switch 26 is secured to frame12 and is provided to terminate the power to the active components ofthe apparatus and prevent further actuation thereof. Preferably,emergency stop switch 26 is positioned in close proximity to diecartridge 20, as shown in FIG. 1, so as to enable the operator toquickly move arm 28 of emergency switch 26 with fingers to shut down ofthe system in the event of an emergency.

Referring now to FIGS. 4 and 5, enlarged views of the needle crimpingzone are illustrated. Guide member 30 is secured to die rotating andcrimping system 16 adjacent die cartridge 20 to perform two functions.First, guide member 30 includes channel 36, shown in FIG. 4, to guidesuture 34 into an appropriately dimensioned opening in the end face ofneedle 24. Second, guide member 30 is a stop member which limits thepositioning of needle 24 between dies 32 so that the dies crimp theneedle at a point where suture 34 will be engaged or crimped by thedeformed surface of the needle. Preferably, guide member 30 isadjustable in the horizontal direction via adjusting screw 38, shown inFIG. 3, and the vertical direction via adjusting screw 40, shown in FIG.5.

Referring now to FIGS. 6-9, the rotating and crimping system 16 of thepresent invention will now be described. Rotating and crimping system 16includes a rotating portion 42 and a crimping portion 44, both of whichare positioned within housing 43, as shown in FIG. 6. As shown in FIGS.6 and 7, rotating portion 42 generally includes a pair of needlecrimping dies 32, rotating die cartridge or member 20, pinion gear 46secured to die cartridge 20 and rack gear 48 which engages pinion gear46 so as to translate linear movement of rack gear 48 to rotationalmovement of die cartridge 20. The working surface 50 of each die 32 ispreferably the "lap-overlap" type, shown in FIG. 8. However, the workingsurface 50 of each die may be of the "clover leaf" type, shown in FIG.9, the staking type (not shown) or the like. One example of a cloverleaf die of this type is described in commonly assigned U.S. Pat. No.5,099,676 to Proto et al. Another example of a preferred dieconfiguration is illustrated in U.S. Pat. No. 5,046,350 to Proto et al.

Referring again to FIGS. 6-7, dies 32 are positioned on die cartridge 20such that the working surface 50 of each die 32 oppose each other and atleast one of the dies is slidably secured thereto. Preferably, both diesare positioned within channels 51 in the form of die cartridge 20 andare slidably retained therein, as shown in FIG. 7. Arcuate spring 52 inthe form of a large circlip as shown, is positioned within arcuatechannel 53 of die cartridge 20 so that each end portion of arcuatespring 52 engages a corresponding die channel 58 in each die 32, asshown in FIG. 10. The dies 32 and arcuate spring 52 are then secured todie cartridge 20 by removable plates 54 and 56. In this configuration,spring 52 normally biases dies 32 in directions away from the center ofdie cartridge 20.

Referring to FIG. 6, rotating portion 42 is shown. Rack gear 48 includesgear section 60 attached to linear drive section 62. Gear section 60 ofrack gear 48 is configured to engage pinion gear 46, as mentioned above.Preferably, linear drive section 62 is a pneumatic pump which iscontrolled by control panel 14, as will be discussed hereinbelow.However, drive section 50 may be any known drive system, such as anelectric motor or hydraulic pump.

Continuing to refer to FIG. 6, the crimping portion 44 will now bedescribed. Crimping portion 44 includes a pair of crimping arms 64 and66 which are pivotally secured to crimping drive member 68 by pin 70.Each crimping arm is substantially identical and provided to selectivelycause dies 32 to bias toward the center of die cartridge 20. Crimpingarm 64 includes a pair of lever arms 72 and 74 which are pivotallyconnected to pivot arm 76 via cross-bars 78 and 80 and pins 82. Inaddition, securing pins 73, positioned on the upper portion of leverarms 72 and 74, and securing pin 75 positioned on pivot arm 76 areprovided to maintain lever arms 72 and 74 in a fixed pivotalrelationship within housing 43. This relationship is maintained suchthat lever arms 72 and 74 and cross bars 78 and 80 form a "U" shapedchamber to partially receive die cartridge 20, as shown in FIG. 6. Pivotarm 76 is also pivotally secured to articulating arm 84 by pin 86, andarticulating arm 84 is secured to crimping drive member 68 by pin 70.

Similarly, crimping arm 66 includes a pair of lever arms 88 and 90 whichare pivotally connected to pivot arm 92 via cross-bars 94 and 96 andpins 98. In addition, securing pins 77, positioned on the upper portionof lever arms 88 and 90, and securing pin 79 positioned on pivot arm 92are provided to maintain lever arms 88 and 90 in a fixed pivotalrelationship within housing 43 so that lever arms 88 and 90 andcross-bars 94 and 96 form a "U" shaped chamber to partially receive diecartridge 20, as shown in FIG. 6.

Preferably, lever arms 88 and 90 are positioned about the die cartridge90° out of phase from lever arms 72 and 74 as shown. This configurationprovides uniform crimping of suture 34 to needle 24. Pivot arm 92 isalso pivotally secured to articulating arm 100 by pin 102 andarticulating arm 100 is pivotally secured to crimping drive member 68 bypin 70. Also, preferably, crimping drive member 68 is connected to apneumatic pump 69 as shown, which is operator controlled at controlpanel 14, as will be discussed below. However, crimping drive member 68may be connected to any other known type of drive system, such as anelectric motor or a hydraulic pump, etc.

The operation of the apparatus of the present invention will now bedescribed with particular reference to FIGS. 11-20 in conjunction withFIGS. 1-6. Generally, when the dies are in the crimping positionpneumatic pump 69 causes crimping drive member 68 to be located at thecenter of its stroke. When the dies are in the open position crimpingdrive member 68 is at either the extended or retracted end of its strokeas determined by pneumatic pump 69.

Referring now to FIG. 11, initially die cartridge 20 is positioned inthe normal position, i.e., crimping drive member 68 is at the extendedend of the stroke and dies 32 are in the open position and horizontallyorientated as shown. However, depending upon the desired sequence,crimping drive member 68 could initially be at the retracted end of thestroke when in the normal position. As mentioned above, securing pins73, 75, 77 and 79 maintain each corresponding pair of lever arms in afixed pivotal relationship within housing 43, thus, when the stroke ofcrimping drive member 68 moves toward the extended end, shown by arrowE, articulating arm 84 pivots causing pivotal movement of pivot arm 76about securing pin 75 via pin 86. As a result, obtuse angle "F", shownin FIG. 6, is decreased to acute angle "G", shown in FIG. 11. Thedescribed pivotal motion of pivot arm 76 causes lever arms 72 and 74 topivot away from the center of die cartridge 20, shown by arrows "H" and"J", in response to pivotal movement of cross bars 78 and 80. Similarly,articulating arm 100 pivots in response to the above described motion ofcrimping drive member 68, causing pivot arm 92 to pivot about securingpin 79 via pin 102. As a result, obtuse angle K, shown in FIG. 6, isdecreased to acute angle L, shown in FIG. 11. The described pivotalmotion of pivot arm 92 causes lever arms 88 and 90 to pivot away fromthe center of die cartridge 20, shown by arrows M and N, in response topivotal movement of cross-bars 94 and 96. As a result of the movement bylever arms 72 and 74 away from the center of die cartridge 20, pusherpins 104 and 106 disengage dies 32 so as to allow dies 32 to biastowards their normal position in response to arcuate spring 52, as notedabove.

When dies 32 are in the open position, the operator inserts a needle 24between dies 32 until the needle face abuts guide member 30, as shown inFIG. 5. The operator then activates control panel 14 so that dies 32 andneedle grippers 22 are respectively set to a preset position. Toactivate control panel 14, a center pivot foot pedal (not shown) may beutilized which will set dies 32 and needle grippers 22 to the presetposition when tilted in one direction and activate the crimping cyclewhen tilted in the other direction. As shown in FIG. 12, the presetposition is the position where dies 32 grasp needle 24 with a force,exerted by pusher pins 104 and 106, sufficient to maintain needle 24therebetween without substantially deforming the needle. The preferredforce is about 10 psi. Either simultaneously with the preset gripping bydies 32 or after a time delay of approximately two seconds, needlegrippers 22 also grasp needle 24 to maintain the position of the needleduring the crimping cycle of the apparatus, as shown in FIGS. 3 and 4.Reset switch 108 is provided to allow the operator to reset the crimpingsystem from the preset position by causing control panel 14 to open dies32 and needle grippers 22 via crimping portion 44. Once in the presetposition, a suture 34 is inserted into the needle bore via guide member30, as described above.

After insertion of suture 34 the crimping cycle is activated by controlpanel 14. As mentioned above, the foot pedal is preferably utilized toactivate the crimping cycle. Generally, the crimping cycle includes twosteps. The first step crimps the needle on two sides and the second steprotates the dies and crimps the needle on two sides which are out ofphase with the sides originally crimped, as shown in FIGS. 13 and 14.Preferably, the second crimping action is 90° out of phase with thefirst crimping action to ensure a uniform attachment of the suture tothe needle. It should be noted that for each part of the crimping cyclethe dies are caused to impact the needle twice so as to ensuresufficient and uniform crimping of the suture within the needle bore.

Referring to FIGS. 11 and 15, the first step of the crimping cyclecauses crimping drive member 68 to move towards the center of the strokeso that pusher pins 104 and 106 bias dies 32 towards needle 24sufficiently to deform the needle surface with the working surface ofeach die and secure suture 34 thereto. Preferably, the force applied todeform needle 24 by pusher pins 104 and 106 is between about 40 psi andabout 80 psi. After deforming the needle surface, the dies are caused toreturn to the open position shown in FIG. 11 by moving crimping drivemember to either the extended or retracted end of the stroke asdescribed above.

Once the first part of the crimping cycle is completed the apparatusautomatically rotates die cartridge 20 so that each die 32 is shifted apredetermined distance from their normal position, preferably about 90°.As previously mentioned, rotational movement of die cartridge 20 occurswhen linear drive section 62, shown in FIG. 6, retracts gear section 48,shown by arrow P in FIG. 16.

Referring now to FIGS. 17 and 18, after rotating die cartridge 20,crimping portion 44 is again activated so that pusher pins 110 and 112bias dies 32 towards needle 24 sufficiently to deform the needle surfacewith the working surface of each die 32 thus, securing suture 34 toneedle 24 in a uniform manner. As mentioned above, it is preferred thatfor each part of the crimping cycle the needle and suture are impactedtwice. After completing the second part of the crimp cycle the dies areagain opened by causing crimping drive member 68 to extend or retract tothe end of the stroke, as shown in FIG. 16. Once the dies are opened theoperator may remove the crimped needle and suture, shown in FIGS. 19 and20.

The present invention also provides an automatic system whichsequentially presents surgical needles to the above described dierotating and crimping system 16 and will be described with reference toFIGS. 21-40. The needle presenting system 210 includes needle bowl 212,rail feeding system 214, pick and place system 216, needle pusher system218 and control system 220 which in this embodiment, replaces controlpanel 14 shown in FIG. 1 and described above, provides the electricaland pneumatic controls for die rotating and crimping system 16 andneedle presenting system 210. Preferably, control system 220, shown inFIG. 27, is the model FP-324, manufactured by Action Automation andControls, located at 10 Larsen Way, North Attleboro, Mass. 02763.

Referring to FIGS. 21-25, needle bowl 212 is preferably in the form of acylinder having ramps secured to or formed on the side wall 222 of bowl212 and sweeps formed on the base 224 of bowl 212. The ramps and sweepsare configured to properly orientate and feed the needles to railfeeding system 214. Bowl 212 is positioned on vibrating frame 226 whichvibrates the bowl sufficiently to cause needles to be dispersed aroundthe bowl and to traverse along the ramp for presentation to rail feedingsystem 214. As shown in FIG. 22, needle pad 228 is positioned at thecenter of base 224 of bowl 212 and is provided to reduce the occurrencesof needle point damage when placing the needles into the bowl. Fromneedle pad 228 the needles are dispersed throughout bowl 212 by thevibratory action of the bowl so that the needles are adjacent to theside wall of the bowl. The vibratory action of bowl 212 also causes theneedles to move around base 224 along sweeps 230 and 232 for properorientation while substantially avoiding needle point damage. Forexample, as shown in FIG. 23, sweep 232 orients needles 234 having thecurved portion 234a facing the center of the bowl so that curved portion234a of needle 234 is adjacent to side wall 222 of the bowl.

As noted above and as shown in FIG. 24, the vibration of bowl 212 alsocauses the needles to proceed along ramp 236 for presentation to railfeeding system 214. Ramp 236 is secured to or formed into side wall 222so as to form a spiral shaped member and includes upper surface 238configured to support the needles. Ramp 236 facilitates movement of theneedle from base 224 of bowl 212 up along side wall 222 to a positionwhere the needle can be presented to rail feeding system 214.Preferably, as shown in FIG. 22, lower portion 240 of ramp 236 isnarrowed at point 242 which causes any needles which may have traversedalong ramp 236 with curved portion 234a facing the center of bowl 212 tofall off the ramp back to the bottom of the bowl thereby properlyorientating the needles. In this arrangement, the narrowing of ramp 236allows the weight of the needle barrel to cause the needle to fall offthe ramp.

In the preferred embodiment, bowl 212 is an uncoated stainless steelbowl which utilizes a unique construction (e.g., sweeps 230 and 232 andramp 236) to prevent damage to the needle point while the needles aredispersed within the bowl, traversed along ramp 236 and properlyoriented for presentation to rail feeding system 214. However, bowl 212may be coated with a protective coating, such as polyurethane, tofurther ensure that the needle points are not damaged.

Referring again to FIG. 21, the vibratory portion of the bowl utilizes atransformer 244 secured to vibrating frame 226 which vibrates the bowlwhen a voltage is applied to transformer 244. The voltage applied to thetransformer may be varied to either increase or decrease the rate ofvibration. One skilled in the art would know the various techniques forvarying the voltage to transformer 224.

Referring now to FIGS. 24-27, when the needles reach upper portion 246of ramp 236 (i.e., the rail presenting position) the needle passes tothe rail feeding assembly 214. Further movement of the needle along ramp236 is prevented by stop 248 (shown in phantom in FIG. 24). Preferably,stop 248 is fabricated from an elastomeric material to prevent damage tothe needle, in particular, the needle point. Once at the rail presentingposition, the needles pass through opening 250 of side wall 222 ontorail 252, preferably, in a counter-clockwise motion as shown in FIGS. 25and 26. Needle block 254 and needle guide 256, shown in FIGS. 25 and 27,are secured to rail 252 and/or rail holder 258 and are provided to guidethe needle onto the rail without causing damage to the needle point.Preferably needle guide 256 is fabricated from an elastomeric materialto minimize damage to the needle point.

Needle block 254 is also provided to properly orient the needles on rail252 prior to presentation to pick and place system 216. To accomplishthis, the weight distribution along the needle is utilized. Typically,the pointed end portion 234b of the needle is lighter then the barrelend portion 234c. Therefore, if the barrel end portion of the needle isoriented against needle block 254 the needle is properly oriented onrail 252 and remains thereon, as shown in FIG. 25. If, however, theneedle is presented with barrel end portion 234c facing the side of rail252 opposite needle block 254, the weight of the barrel forces theneedle to rotate counter-clockwise and fall off rail 252, as shown inFIG. 26. Recovery tray 260 is secured to or formed into bowl 252 and isprovided to receive the needles which fall off of rail 252. Preferably,recovery tray 260, shown in FIGS. 24 and 26, has bottom surface 262which is sloped so that needles 234 slide toward opening 264 in sidewall 222, shown in FIG. 24, and into bowl 212 for redistribution withinthe bowl and presentation to rail feeding system 214 in the mannerdescribed above. A protective coating, such as polyurethane, may beapplied to bottom surface 262 of tray 260 to further minimize needlepoint damage.

Referring now to FIG. 25, preferably, rail 252 is a cylindrical memberwhich has a radius of curvature that is less than or equal to the radiusof curvature of curved portion 234a of needle 234. As a result, when theneedles are properly resting on rail 252 as shown in FIG. 25, the needlepoint portion 234b of the needle is offset from the rail so as toprevent the needle point from engaging the surface of the rail. Intypical applications, rail 252 is fabricated from stainless steel, thusif the needle point portion engages or otherwise contacts the hardenedsurface of the rail, needle point damage may occur. The offset betweenthe needle point and the rail prevents the inadvertent contacttherebetween.

Turning to FIG. 27, rail 252 is operatively connected to vibratingtransformer 266 via rail holder 258 to cause the needles to sequentiallyadvance along the rail toward a presenting position for pick and placesystem 216. The rate of vibration of the rail may be varied by adjustingthe voltage applied to the transformer. As noted above, one skilled inthe art would know the various techniques for varying an applied voltageto increase or decrease the vibration of the rail. In thisconfiguration, multiple needles can be moved along rail 252 and storedthereon until picked or grabbed by pick and place system 216.Photoproximity switch 268 is positioned on support arm 270 and isoperatively connected to rail transformer 266 and to bowl transformer244. Photoproximity switch 260 selectively deactivates the transformerin response to the presence of needles within the activation zone of thephotoproximity switch until the needle has advanced past the switch.

Referring to FIGS. 28 and 29, needle guide arm 272 is secured to railholder 258 via guide bracket 274 and is utilized to maintain the needleon rail 252 and prevent needles from becoming dislodged therefrom.Needle guide arm 272 is adjustable so that it can accommodate thevarious size needle diameters utilized in surgical applications. Toadjust guide arm 272, the operator simply loosens bolts 276 and slidesthe guide arm within slots 278.

In an alternative embodiment shown in FIG. 30, rail 252 may be removablysecured to rail vibrating transformer 266 so that rail 252 may beutilized for storing needles and/or transporting needles betweenassembly stations. In this embodiment, vibrating transformer 266includes interlocking flange 280 which is positioned into engagementwith interlocking channel 282 of rail holder 258. Locking lever 284which is rotatably secured to rail 252, is rotated into a lockingengagement with locking channel 286 in vibrating transformer 266, thuslocking rail 252 to transformer 266. To remove the rail from thetransformer, an operator simply rotates locking lever 284 out ofengagement with locking channel 286 and disengages interlocking channel282 from interlocking flange 280.

Referring again to FIG. 28 and as noted above, the needles are traversedalong the rail 252 to the position for presentation to pick and placesystem 216. Each needle is then sequentially picked from rail 252 viapick and place system 216. As shown, spacer bar 288 is secured to theend of rail 252 and is provided to prevent the needles from falling offthe rail and to facilitate gripping of the needle by jaws 290 of pickand place system 216. Preferably, the upper portion 292 of spacer bar288 is beveled so as to enable the jaws of the pick and place system tograb the curved portion 234a of needle 234.

The pick and place system of the present invention will now be describedwith reference to FIGS. 27 and 31. As shown, pick and place system 216includes jaws 290 movably secured to head 294, which are manipulated tograb needle 234 and thereafter place the needle onto needle pushersystem 218 for subsequent processing. The drive mechanism for pick andplace system 216 utilizes pneumatic pistons which respond to signalsfrom control system 220 and facilitate vertical, horizontal androtational movement of head 294, as well as, the opening and closingmovement of jaws 290. Such pneumatic systems are known to those skilledin the art. In addition, other known sources may be utilized to move thehead and jaws, for example, servo motors which are operatively connectedto control system 220.

An illustration of the operational movement of jaws 290 and head 294when it grabs a needle and deposits the needle onto needle pusher system218 will be described with reference to FIGS. 31 and 32. Initially, jaws290 of pick and place system 216 close to grab the first needle 234 atthe end of rail 252. At this point, head 294 is then moved in a verticaldirection, shown by arrow "R", away from rail 252 and then along ahorizontal direction, shown by arrow "S", to a position in alignedcommunication with track 296 of needle pusher system 218. Thereafter,head 294 is rotated approximately 90°, shown by arrow "T", to cause theneedle to align in a substantial parallel orientation to base plate 18of needle pusher system 218, as shown. Head 294 is then lowered to apoint adjacent base plate 18 and jaws 290 are opened to deposit theneedle onto track 296 so that the needle point portion 234b and thebarrel end portion 234c of the needle, face die rotating and crimpingsystem 16, as shown in FIG. 32. Once the needle is released from jaws290, head 294 is then retracted in a vertical direction, shown by arrow"U", and head 294 is rotated approximately 90°, shown by arrow "V", sothat jaws 290 are in a position to grab the next needle presented onrail 252.

At the same time or shortly after the needle is deposited onto needlepusher system 218, pusher unit 298 is activated by control system 220 tocause the needle to slide within track 296 toward the above describeddie rotating and crimping system. As shown in FIGS. 32-34, when theneedle is deposited onto needle pusher assembly 218, curved portion 234aof needle 234 is facing the rear of pusher assembly 298. Thus when theneedle is moved within track 296, the barrel end portion 234c of theneedle is aligned with the needle gripper which maintains the needle ina fixed position to facilitate placement of the suture into the drilledend of the needle barrel portion.

When sliding the needle along track 296 the weight of the barrel portionof the needle has a tendency to cause barrel end portion 234c to lagbehind the pointed end portion 234b of the needle. Delrin spring 300 isutilized to compensate for the lag by engaging pointed end portion 234cprior to the completion of the movement of pusher unit 298, thus causingbarrel end portion 234c to rotate, shown by arrow "W" (FIG. 33), intoposition between dies 32 of die rotating and crimping system 16. Theresilient features of spring 300 allow final positioning of the needlefor swaging without damaging the pointed end portion of the needle, asshown in FIG. 33.

Continuing to refer to FIGS. 33 and 34, the preferred pusher unit 298includes pusher arm 302, drive arm 304, piston 306 and limit switch 308.Preferably, piston 306 is a pneumatic piston which is responsive tocontrol signals received from control system 220. Thus, after jaws 290of pick and place system 216 deposit the needle onto track 296, apredetermined period of time may be allowed to lapse prior to activationof piston 306. Activation of piston 306 causes pusher arm 302 to moveneedle 234 toward die rotating and crimping system 16. Limit switch 308is secured to base plate 18 and is provided to limit the movement ofpusher arm 302 so as to position the barrel end portion of the needlebetween dies 32 of die rotating and crimping system 16 for subsequentcrimping or swaging. Once the needle is positioned between dies 32,i.e., limit switch 308 is activated, pusher arm 302 is retracted, inresponse to retraction of piston 306, to receive the next needledeposited from the pick and place system.

The present invention also provides manual and automatic suture guideassemblies which may be used to replace guide member 30 described aboveand shown in FIG. 4. Manual suture guide assembly 310, shown in FIGS. 32and 35, is secured to die rotating and crimping system 16 and isprovided to guide the insertion of a suture into the bore in the barrelend portion of the needle. The suture guide assembly 310 also limits themovement of the needle as it is positioned between dies 32. As shown,suture guide assembly 310 includes stationary guide arm 312 and pivotingguide arm 314 both of which are secured to support member 316. Eachguide arm includes semi-circular portions 318 and 320, respectively,which form the opening to guide the suture into the bore in the needlewhen the guide arms are in the closed position. Preferably, as shown inFIG. 35A, portions 318 and 320 are tapered to allow a wide insertionportion where an operator can insert the suture and which narrows to theapproximate diameter of the bore in the needle to guide the suture intothe bore. Pivoting guide arm 314 is pivotally secured to support member316 via pivot pin 322 and lever arm 324 is provided to allow theoperator to pivot guide arm 314 and remove the swaged surgical suture.Preferably, as shown in FIG. 35, suture guide assembly 310 includesthumb screws 326 and 328 which allow vertical and horizontal adjustmentof the guide arms for proper alignment with dies 32 and the needle bore.

The automatic suture guide assembly of the present invention is shown inFIGS. 36-40. Automatic suture guide assembly 330 is secured to dierotating and crimping system 16 and is provided to limit the movement ofthe needle as it is positioned between dies 32, to guide the insertionof a suture into the drilled end of the needle, i.e., the needle bore,prior to swaging, and to automatically open the guide arms to allowremoval of the swaged surgical suture. Automatic suture guide assembly330 includes stationary guide arm 332 which is secured to support member334 and movable guide arm 336. Each guide arm includes taperedsemi-circular portions 338 and 340 which are similar to the abovedescribed semi-circular portions 318 and 320 and which guide the sutureinto the bore in the end face of the barrel end portion of the needle.

Movable guide arm 336 is secured to piston arm 342 which moves the guidearm between an open position, shown in FIG. 37 and a closed position,shown in FIG. 38, in response to control signals from control system220. Piston arm 342 is slidably positioned through adjusting frame 344into drive cylinder assembly 346. Preferably, drive cylinder assembly346 is a pneumatic cylinder responsive to control signals received fromcontrol system 220.

Referring to FIGS. 39 and 40, adjusting frame 344 includes thumb screws346, 348 and 350 which facilitate adjustment of the guide arms 332 and336 so that the guide arms properly align with dies 32 of die rotatingand crimping system 16 and the needle bore.

Once the needles are gripped by needle gripper 22, shown in FIGS. 2-4and described above, a predetermined period of time may be allowed tolapse before control system 220 activates the above described dierotating and crimping system 16 which operates in a manner describedabove.

It will be understood that various modifications can be made to theembodiments of the present invention herein disclosed without departingfrom the spirit and scope thereof. For example, various sizes of theinstrument are contemplated, as well as various types of constructionmaterials. Also, various modifications may be made in the configurationof the parts. Therefore, the above description should not be construedas limiting the invention but merely as exemplifications of preferredembodiments thereof. Those skilled in the art will envision othermodifications within the scope and spirit of the present invention asdefined by the claims appended hereto.

What is claimed is:
 1. Apparatus for feeding surgical needles to asuture crimping apparatus, which comprises:a container for receivingcurved surgical needles and orientating the surgical needles in apredefined position for subsequent processing; a transmission member forreceiving the orientated needles from said container at a receivingposition and transferring the needles to a presenting position; meansfor transferring the needles between said presenting position and acrimping position, said transferring means including: means for graspingneedles in said presenting position and for transferring said graspedneedle to a needle pusher track; and means for moving the needle alongsaid pusher track to said crimping position.
 2. The apparatus accordingto claim 1, wherein said container comprises a vibratory bowl having atleast one sweep positioned on a bottom portion of said bowl and at leastone ramp which transfers the needles from said bottom portion of thebowl to said receiving position, said receiving position being locatedat a side wall portion of said bowl.
 3. The apparatus according to claim2, wherein said at least one sweep is configured and dimensioned toorient a curved portion of the needles against said side wall of saidbowl.
 4. The apparatus according to claim 2, wherein said at least oneramp comprises a single ramp secured to said side wall of said bowl soas to define a substantially spiral shape member which extends alongsaid side wall from said bottom portion to said receiving position. 5.The apparatus according to claim 1, wherein said transmission membercomprises a vibratory rail having a substantially cylindrical shape andwhich is adapted to support and transfer the needles to said presentingposition.
 6. The apparatus according to claim 1, wherein said graspingand transferring means comprisesa drive member adapted for movementbetween said presenting position and said crimping position; and a pairof jaws secured to said drive member and movable between an openposition and a closed position.
 7. Apparatus for feeding surgicalneedles to a suture crimping apparatus, which comprises:a container forreceiving curved surgical needles and orientating the surgical needlesin a predefined position for subsequent processing, said containerincluding a vibratory bowl having at least one sweep positioned on abottom portion of said bowl and at least one ramp which transfers theneedles from said bottom portion of the bowl to a receiving position,said receiving position being located at a side wall portion of saidbowl, said vibratory bowl being coated with polyurethane; a transmissionmember for receiving the orientated needles from said container at saidreceiving position and transferring the needles to a presentingposition; and means for transferring the needles between said presentingposition and a crimping position.
 8. Apparatus for feeding surgicalneedles to a suture crimping apparatus, which comprises:a container forreceiving curved surgical needles and orientating the surgical needlesin a predefined position for subsequent processing; a transmissionmember for receiving the orientated needles from said container at areceiving position and transferring the needles to a presentingposition, said transmission member including a vibratory rail having asubstantially cylindrical shape and which is adapted to support andtransfer the needles to said present position, said rail having a radiusequal to or less than the radius of curvature of the curved surgicalneedle; and means for transferring the needles between said presentingposition and a crimping position.
 9. Apparatus for receiving andorienting curved surgical needles, which comprises a container having abase, at least one side wall and a needle receiving member positioned onsaid base, said container having at least one sweep positioned on saidbase for orienting curved surgical needles to a predeterminedorientation and at least one ramp for processing the curved surgicalneedles from said base to a needle presenting position on said sidewall, said container being coated with a polymer whereby damage topoints of the needles is substantially avoided.
 10. The apparatusaccording to claim 9 further comprising means for vibrating saidcontainer at a predetermined rate.
 11. The apparatus according to claim10, wherein said vibrating means comprises a frame adapted to supportsaid container and a transformer for vibrating said frame.
 12. Theapparatus according to claim 9, wherein said container comprises astainless-steel bowl.
 13. Apparatus for feeding surgical needles to asuture crimping apparatus while minimizing needle point damage, whichcomprises:a container for receiving curved surgical needles andorientating the surgical needles in a predefined position for subsequentprocessing whereby damage to needle points is substantially avoided; atransmission member for receiving the orientated needles from saidcontainer at a receiving position and transferring the needles to apresenting position whereby damage to said needle points issubstantially avoided; a drive member adapted for movement between saidpresenting position and a crimping position; a pair of jaws secured tosaid drive member and movable between an open position and a closedposition to grasp and transfer a needle to a needle pusher track; and apusher unit to move the needles along said needle pusher track wherebydamage to said needle points is substantially avoided.
 14. Apparatus forfeeding surgical needles to a needle crimping apparatus while minimizingneedle point damage, which comprises:a container configured to receivecurved surgical needles, said container having a sweep member disposedwithin said container and configured to orient the surgical needles in apredefined position for subsequent processing; a transmission memberoperatively associated with said container, said transmission memberreceiving the orientated needles from said container at a receivingposition and transferring the needles to a presenting position; a drivemember mounted for movement between said presenting position and acrimping position; a pair of jaws secured to said drive member andmovable between an open position and a closed position to grasp andtransfer a needle from said presenting position to a needle pushertrack; and a pusher unit operatively associated with said needle pushertrack to move the needles along said needle pusher track to saidcrimping position, whereby damage to said needle points is substantiallyavoided as said needles are moved to said crimping position.